PROCLAIM-CX-2009: A Trial to Find Safe and Active Doses of an Investigational Drug CX-2009 for Patients With Selected Solid Tumors

Status: Active

Description

The purpose of this first-in-human study of CX-2009 is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of CX-2009 in adult subjects with metastatic or locally advanced unresectable solid tumors. PROCLAIM: PRObody CLinical Assessment In Man CX-2009 clinical trial 001 PROBODY is a trademark of CytomX Therapeutics, Inc

Eligibility Criteria

Inclusion Criteria

  • Histologically confirmed diagnosis of metastatic or locally advanced unresectable tumors
  • Patients demonstrating disease progression after treatment with available therapies that are known to confer clinical benefit, or who are intolerant to treatment,
  • Agreement to provide mandatory archival tissue or fresh biopsy.
  • At least 18 years of age.

Exclusion Criteria

  • Active or chronic corneal disorder, history of corneal transplantation, active herpetic keratitis, and active ocular conditions requiring ongoing treatment/monitoring
  • Serious concurrent illness, including clinically relevant active infection
  • History of or current active autoimmune diseases
  • Significant cardiac disease such as recent myocardial infarction
  • History of multiple sclerosis or other demyelinating disease, Eaton-Lambert syndrome (para-neoplastic syndrome), history of hemorrhagic or ischemic stroke within the last 6 months, or alcoholic liver disease;
  • Non-healing wound(s) or ulcer(s) except for ulcerative lesions caused by the underlying neoplasm;
  • History of severe allergic or anaphylactic reactions to previous monoclonal antibody therapy;
  • Currently receiving anticoagulation therapy with warfarin;
  • Major surgery (requiring general anesthesia) within 3 months prior to dosing.

Locations & Contacts

California

Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: Active
Contact: Rose Estrada
Phone: 310-633-8400
Email: RoseEstrada@mednet.ucla.edu
USC / Norris Comprehensive Cancer Center
Status: Active
Name Not Available

Illinois

Chicago
University of Chicago Comprehensive Cancer Center
Status: Active
Name Not Available

Indiana

Indianapolis
Indiana University / Melvin and Bren Simon Cancer Center
Status: Temporarily closed to accrual
Contact: Suzanne Marie Bailey
Phone: 317-278-4694
Email: subailey@iupui.edu

Massachusetts

Boston
Brigham and Women's Hospital
Status: Active
Name Not Available
Dana-Farber Cancer Institute
Status: Active
Name Not Available

Michigan

Detroit
Wayne State University / Karmanos Cancer Institute
Status: Temporarily closed to accrual
Name Not Available

New York

Buffalo
Roswell Park Cancer Institute
Status: Active
Name Not Available
New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: Active
Contact: Luca Paoluzzi
Phone: 212-731-6667
Email: Luca.Paoluzzi@nyumc.org
Memorial Sloan Kettering Cancer Center
Status: Active
Name Not Available
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: Active
Name Not Available

Texas

Houston
M D Anderson Cancer Center
Status: Active
Name Not Available

Utah

Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: Active
Name Not Available

Wisconsin

Madison
University of Wisconsin Hospital and Clinics
Status: Active
Name Not Available

Trial Phase & Type

Trial Phase

Phase I/II

Trial Type

Treatment

Lead Organization

Lead Organization
CytomX Therapeutics

Trial IDs

Primary ID CTMX-M-2009-001
Secondary IDs NCI-2017-00915
Clinicaltrials.gov ID NCT03149549